Mefloquine hydrochloride - Generic Drug Details

What are the generic sources for mefloquine hydrochloride and what is the scope of freedom to operate?

Mefloquine hydrochloride is the generic ingredient in two branded drugs marketed by Roche, Barr, Hikma, Hikma Intl Pharms, Sandoz, and Us Army Walter Reed, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for mefloquine hydrochloride. Three suppliers are listed for this compound.

Summary for mefloquine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	145
Clinical Trials:	77
Patent Applications:	2,133
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in mefloquine hydrochloride?	mefloquine hydrochloride excipients list
DailyMed Link:	mefloquine hydrochloride at DailyMed

Recent Clinical Trials for mefloquine hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Research and Innovation Agency of Indonesia	N/A
Universitas Padjadjaran	N/A
Prodia Diacro Laboratories P.T.	N/A

See all mefloquine hydrochloride clinical trials

Pharmacology for mefloquine hydrochloride

Drug Class

Antimalarial

Medical Subject Heading (MeSH) Categories for mefloquine hydrochloride

Antimalarials

Anatomical Therapeutic Chemical (ATC) Classes for mefloquine hydrochloride

P01BC	Methanolquinolines
P01B	ANTIMALARIALS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for mefloquine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	LARIAM	mefloquine hydrochloride	TABLET;ORAL	019591-001	May 2, 1989		DISCN	Yes	No
Sandoz	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	076175-001	Feb 20, 2002		DISCN	No	No
Hikma	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	076523-001	Oct 1, 2004	AB	RX	No	No
Hikma Intl Pharms	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	077699-001	Apr 21, 2010		DISCN	No	No
Us Army Walter Reed	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	019578-001	May 2, 1989		DISCN	No	No
Barr	MEFLOQUINE HYDROCHLORIDE	mefloquine hydrochloride	TABLET;ORAL	076392-001	Dec 29, 2003	AB	RX	No	Yes

Expired US Patents for mefloquine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	LARIAM	mefloquine hydrochloride	TABLET;ORAL	019591-001	May 2, 1989